Levothyroxine Sodium

   
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Levothyroxine Sodium


Drug - Levothyroxine Sodium
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Levothyroxine Sodium
Multiple ingredients are in alphabetical order.

Strength - 0.05MG **See Current Cumulative Supplement 1.3
The potency of the active ingredient(s), Levothyroxine Sodium. May repeat for multiple part products.

Applicant - GENPHARM
The firm name holding legal responsibility for Levothyroxine Sodium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076752
The FDA assigned number to Levothyroxine Sodium. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Levothyroxine Sodium. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB2
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jun 16, 2005
The date Levothyroxine Sodium was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Levothyroxine Sodium. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Levothyroxine Sodium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Genpharm Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Levothyroxine Sodium.

Levothyroxine Sodium